Clinical trial • Phase III • Respiratory

CAMLIPIXANT for Refractory chronic cough | Unexplained chronic cough

Phase III trial of CAMLIPIXANT for Refractory chronic cough | Unexplained chronic cough.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Refractory chronic cough | Unexplained chronic cough
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-09-2024
First CTIS Authorization Date
24-09-2024

Trial design

Randomised, open-label, placebo (matching tablets); no dose specified for placebo-controlled Phase III trial in Netherlands, Poland, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (matching tablets); no dose specified for placebo
Target Sample Size
592
Trial Duration For Participant
364

Eligibility

Recruits 592 The record indicates isVulnerablePopulationSelected = true. Inclusion requires participants to be "Capable of understanding the written informed consent", indicating that adults must provide written informed consent; no further details on assent or additional consent procedures for specific vulnerable groups are provided in the available data..

Pregnancy Exclusion
5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance
Vulnerable Population
The record indicates isVulnerablePopulationSelected = true. Inclusion requires participants to be "Capable of understanding the written informed consent", indicating that adults must provide written informed consent; no further details on assent or additional consent procedures for specific vulnerable groups are provided in the available data.

Inclusion criteria

  • {"criterion_text":"- 1. Between 18 and 80 years of age inclusive"}
  • {"criterion_text":"- 2. Capable of understanding the written informed consent"}
  • {"criterion_text":"- 3. Diagnosis of Refractory chronic cough (including unexplained chronic cough) for ≥ 1 year prior to Screening"}
  • {"criterion_text":"- 4. Participants must meet the cough frequency criteria"}
  • {"criterion_text":"- 5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance"}

Exclusion criteria

  • {"criterion_text":"- 1. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vapors or individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history"}
  • {"criterion_text":"- 2. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or uncontrolled asthma"}
  • {"criterion_text":"- 3. History of upper and/or lower respiratory tract infection or significant change in pulmonary status within 28 days of Screening"}
  • {"criterion_text":"- 4. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening"}
  • {"criterion_text":"- 5. Medical history of malignancy and treatment completed ≤ 5 years prior to Screening"}
  • {"criterion_text":"- 6. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years"}
  • {"criterion_text":"- 7. Positive serological test for HIV, hepatitis B, or hepatitis C at Screening"}
  • {"criterion_text":"- 8. Previous participation in an investigational study of BLU-5937 For the full list of exclusion criteria please refer to the study protocol."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 24-hour cough frequency at Week 12 by a cough monitor.","definition_or_measurement_approach":"Measured by a cough monitor; assessment at Week 12 (24-hour cough frequency)."}
  • {"endpoint_text":"- Incidence of AEs and SAEs up to Week 52","definition_or_measurement_approach":"Capture and reporting of adverse events (AEs) and serious adverse events (SAEs) through Week 52 (incidence counts)."}
  • {"endpoint_text":"- Incidence of AEMIs up to Week 52","definition_or_measurement_approach":"Capture and reporting of adverse events of special interest (AEMIs) through Week 52 (incidence counts)."}
  • {"endpoint_text":"- Occurrences of study treatment discontinuations due to AEs and SAEs up to Week 52","definition_or_measurement_approach":"Recording of treatment discontinuations attributed to AEs or SAEs through Week 52 (occurrence counts)."}
  • {"endpoint_text":"- Occurrences of AEs and SAEs leading to study withdrawal up to Week 52","definition_or_measurement_approach":"Recording of AEs/SAEs that result in withdrawal from the study through Week 52 (occurrence counts)."}

Secondary endpoints

  • {"endpoint_text":"- CS-VAS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from Baseline in CS-VAS at Week 12","definition_or_measurement_approach":"Change from baseline measured using the CS-VAS instrument at Week 12."}
  • {"endpoint_text":"- CS-VAS response at Week 12","definition_or_measurement_approach":"Responder analysis based on CS-VAS at Week 12."}
  • {"endpoint_text":"- Objective cough frequency recording","definition_or_measurement_approach":"Objective cough frequency captured (method: cough monitor/recording)."}
  • {"endpoint_text":"- Awake cough frequency at Week 12","definition_or_measurement_approach":"Objective measurement of cough frequency during awake periods at Week 12."}
  • {"endpoint_text":"- 24-hour cough response at Week 12","definition_or_measurement_approach":"24-hour cough response measured at Week 12 (likely via cough monitor)."}
  • {"endpoint_text":"- LCQ","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from Baseline in the LCQ total score at Week 12","definition_or_measurement_approach":"Change from baseline in Leicester Cough Questionnaire total score at Week 12."}
  • {"endpoint_text":"- LCQ response at Week 12","definition_or_measurement_approach":"Responder analysis based on LCQ at Week 12."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
592
Recruitment Window Months
36
Consent Approach
Adults must be capable of understanding and provide written informed consent ("Capable of understanding the written informed consent"). Subject information and informed consent forms (ICFs/PIS) are available in multiple languages (English, French, Dutch, Polish, Hungarian, Spanish) as indicated in the submitted documents.

Methods

  • Patient Brochure (language-specific versions present: EN, NL, FR, ES)
  • Patient Flyer (language-specific versions: EN, NL, FR, ES)
  • Patient Poster (language-specific versions: EN, NL, FR, ES)
  • Patient Study Guide (EN/NL/FR versions listed)
  • Study Overview Video Storyboard / Study Video (storyboards present in multiple languages)
  • Cough Monitor Instructions Video Storyboard (global EN and language-specific versions)
  • Pre-screener Module / Patient Pre-Screening Website Content
  • DTP call scripts and scheduling scripts (inbound/outbound) for participant contact and scheduling
  • ePR Scheduling Chatbot scripts
  • Participant Journey Emails and Patient eDiary / Medication compliance materials
  • Greenphire ClinCard materials and travel/reimbursement guides (patient reimbursement and travel support)
  • Local recruitment arrangements and consent form documents (K1) and localized ICF/PIS documents

Geography

Total Number Of Sites
55
Total Number Of Participants
275

Netherlands

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
431
Number Of Sites
8
Number Of Participants
27

Sites

Site Name
Catharina Ziekenhuis Stichting
Department Name
pulmonology
Principal Investigator Name
Pascal Wielders
Principal Investigator Email
pascal.wielders@catharinaziekenhuis.nl
Contact Person Name
Pascal Wielders
Site Name
Bernhoven B.V.
Department Name
pulmonology
Principal Investigator Name
JPH Van den Bogart
Principal Investigator Email
m.vandenbogart@bernhoven.nl
Contact Person Name
JPH Van den Bogart
Contact Person Email
m.vandenbogart@bernhoven.nl
Site Name
Isala Klinieken Stichting
Department Name
pulmonology
Principal Investigator Name
Jan Willem van den Berg
Principal Investigator Email
j.w.k.van.den.berg@isala.nl
Contact Person Name
Jan Willem van den Berg
Contact Person Email
j.w.k.van.den.berg@isala.nl
Site Name
Amphia Hospital
Department Name
pulmonology
Principal Investigator Name
Simone van der Sar
Principal Investigator Email
svandersar@amphia.nl
Contact Person Name
Simone van der Sar
Contact Person Email
svandersar@amphia.nl
Site Name
Gelre Hospitals
Department Name
Pulmonology
Principal Investigator Name
Martijn Goosens
Principal Investigator Email
m.goosens@gelre.nl
Contact Person Name
Martijn Goosens
Contact Person Email
m.goosens@gelre.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
pulmonology
Principal Investigator Name
Marjo van de Ven
Principal Investigator Email
mvandeven@rijnstate.nl
Contact Person Name
Marjo van de Ven
Contact Person Email
mvandeven@rijnstate.nl
Site Name
Ziekenhuis St Jansdal
Department Name
pulmonology
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
ln.boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
pulmonology
Principal Investigator Name
Astrid Aardenburg van Huisstede
Principal Investigator Email
a.aardenburg-van.huisstede@nwz.nl
Contact Person Name
Astrid Aardenburg van Huisstede

Poland

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
18-08-2025
Processing Time Days
402
Number Of Sites
10
Number Of Participants
99

Sites

Site Name
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
Principal Investigator Name
Małgorzata Pawlukiewicz
Principal Investigator Email
mpawlu@onet.eu
Contact Person Name
Małgorzata Pawlukiewicz
Contact Person Email
mpawlu@onet.eu
Site Name
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
Principal Investigator Name
Anna Olech-Cudzik
Principal Investigator Email
annacudzik@cudmed.pl
Contact Person Name
Anna Olech-Cudzik
Contact Person Email
annacudzik@cudmed.pl
Site Name
Pratia S.A.
Principal Investigator Name
Jacek Dulęba
Principal Investigator Email
jduleba@pratia.pl
Contact Person Name
Jacek Dulęba
Contact Person Email
jduleba@pratia.pl
Site Name
Centrum Medyczne Lucyna Andrzej Dymek s.c.
Principal Investigator Name
Lucyna Dymek
Principal Investigator Email
ladymek@centrummedyczne.com
Contact Person Name
Lucyna Dymek
Contact Person Email
ladymek@centrummedyczne.com
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi
Department Name
Poradnia Alergologiczna
Principal Investigator Name
Piotr Kuna
Principal Investigator Email
piotr.kuna@umed.lodz.pl
Contact Person Name
Piotr Kuna
Contact Person Email
piotr.kuna@umed.lodz.pl
Site Name
Prywatny Gabinet Internistyczno-Alergologiczny Zenon Siergiejko
Principal Investigator Name
Zenon Sergiejko
Principal Investigator Email
zenonsiergiejko1@gmail.com
Contact Person Name
Zenon Sergiejko
Contact Person Email
zenonsiergiejko1@gmail.com
Site Name
Vitamed Galaj I Cichomski Sp. j.
Principal Investigator Name
Iwona Patyk
Principal Investigator Email
iwonapatyk@yahoo.fr
Contact Person Name
Iwona Patyk
Contact Person Email
iwonapatyk@yahoo.fr
Site Name
Centrum Innowacyjnych Terapii Sp. z o.o.
Principal Investigator Name
Luiza Jonczak
Principal Investigator Email
l.jonczak@etg-network.com
Contact Person Name
Luiza Jonczak
Contact Person Email
l.jonczak@etg-network.com
Site Name
Alergo Med Osrodek Badan Klinicznych Sp. z o.o.
Principal Investigator Name
Bernadetta Majorek-Olechowska
Principal Investigator Email
bernadettaolechowska@gmail.com
Contact Person Name
Bernadetta Majorek-Olechowska
Contact Person Email
bernadettaolechowska@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddzial Kliniczny Pulmunologii i Alergologii
Principal Investigator Name
Wojciech Piotrowski
Principal Investigator Email
wojciech.piotrowski@umed.lodz.pl
Contact Person Name
Wojciech Piotrowski

Belgium

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
12-08-2025
Processing Time Days
396
Number Of Sites
7
Number Of Participants
42

Sites

Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Pneumolgy
Principal Investigator Name
Maud Deschampheleire
Principal Investigator Email
maud.deschampheleire@citadelle.be
Contact Person Name
Maud Deschampheleire
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pneumolgy
Principal Investigator Name
Ingel DEMEDTS
Principal Investigator Email
ingel.demedts@azdelta.be
Contact Person Name
Ingel DEMEDTS
Contact Person Email
ingel.demedts@azdelta.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumolgy
Principal Investigator Name
Charles Pilette
Principal Investigator Email
hcharles.pilette@saintluc.uclouvain.be
Contact Person Name
Charles Pilette
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Pneumolgy
Principal Investigator Name
Martijn Vandebotermet
Principal Investigator Email
studieslongziekten@azgroeninge.be
Contact Person Name
Martijn Vandebotermet
Site Name
A.Z. Sint-Maarten
Department Name
Pneumolgy
Principal Investigator Name
Muriel Lins
Principal Investigator Email
muriel.lins@emmaus.be
Contact Person Name
Muriel Lins
Contact Person Email
muriel.lins@emmaus.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pneumolgy
Principal Investigator Name
Guy Brusselle
Principal Investigator Email
guy.brusselle@uzgent.be
Contact Person Name
Guy Brusselle
Contact Person Email
guy.brusselle@uzgent.be
Site Name
UZ Leuven
Department Name
Pneumolgy
Principal Investigator Name
Lieven Dupont
Principal Investigator Email
lieven.dupont@uzleuven.be
Contact Person Name
Lieven Dupont
Contact Person Email
lieven.dupont@uzleuven.be

France

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
11-08-2025
Processing Time Days
304
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumology
Principal Investigator Name
Naji KHAYATH
Principal Investigator Email
naji.khayath@chru-strasbourg.fr
Contact Person Name
Naji KHAYATH
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Pneumology
Principal Investigator Name
Philippe BONNIAUD
Principal Investigator Email
philippe.bonniaud@chu-dijon.fr
Contact Person Name
Philippe BONNIAUD
Contact Person Email
philippe.bonniaud@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumology
Principal Investigator Name
Nicolas ROCHE
Principal Investigator Email
nicolas.roche@aphp.mssante.fr
Contact Person Name
Nicolas ROCHE
Contact Person Email
nicolas.roche@aphp.mssante.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumology
Principal Investigator Name
Laurent GUILLEMINAULT
Principal Investigator Email
guilleminault.l@chu-toulouse.fr
Contact Person Name
Laurent GUILLEMINAULT
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Pneumology
Principal Investigator Name
Pascal CHANEZ
Principal Investigator Email
pascal.chanez@univ-amu.fr
Contact Person Name
Pascal CHANEZ
Contact Person Email
pascal.chanez@univ-amu.fr
Site Name
Hopital Europeen Marseille
Department Name
Pneumology
Principal Investigator Name
Hervé PEGLIASCO
Principal Investigator Email
h.pegliasco@hopital-europeen.fr
Contact Person Name
Hervé PEGLIASCO
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Pneumology
Principal Investigator Name
Arnaud BOURDIN
Principal Investigator Email
a-bourdin@chu-montpellier.fr
Contact Person Name
Arnaud BOURDIN
Contact Person Email
a-bourdin@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pneumology
Principal Investigator Name
Silvia DEMOULIN
Principal Investigator Email
silvia.alexikova@chu-lille.fr
Contact Person Name
Silvia DEMOULIN
Contact Person Email
silvia.alexikova@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse (additional listed site)
Department Name
Pneumology

Hungary

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
433
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Szalay Janos Rendelointezet
Principal Investigator Name
Edina Kurucz
Principal Investigator Email
drkuruczedina@gmail.com
Contact Person Name
Edina Kurucz
Contact Person Email
drkuruczedina@gmail.com
Site Name
Da Vinci Spa Kft.
Principal Investigator Name
Márta Papp
Principal Investigator Email
drpappm@gmail.com
Contact Person Name
Márta Papp
Contact Person Email
drpappm@gmail.com
Site Name
Püspökladányi Egészségügyi Szolgáltató Intézmény
Principal Investigator Name
Nelli Kosztyu
Principal Investigator Email
nellypharmanex@gmail.com
Contact Person Name
Nelli Kosztyu
Contact Person Email
nellypharmanex@gmail.com
Site Name
DRC Kft.
Principal Investigator Name
Krisztina Czebe
Principal Investigator Email
czebekriszta@gmail.com
Contact Person Name
Krisztina Czebe
Contact Person Email
czebekriszta@gmail.com
Site Name
High Tech Medical Kft.
Principal Investigator Name
Katalin Várdi
Principal Investigator Email
ceo@hightechmedicalkft.com
Contact Person Name
Katalin Várdi
Contact Person Email
ceo@hightechmedicalkft.com
Site Name
Erzsebet Gondozohaz Kft.
Principal Investigator Name
János Mucsi
Principal Investigator Email
mucsitrial@gmail.com
Contact Person Name
János Mucsi
Contact Person Email
mucsitrial@gmail.com
Site Name
Omnimodus Elixir Kft.
Principal Investigator Name
Erika Unger
Principal Investigator Email
ungerstudy@gmail.com
Contact Person Name
Erika Unger
Contact Person Email
ungerstudy@gmail.com
Site Name
Clinexpert Kft.
Principal Investigator Name
Veronika Urbán
Principal Investigator Email
nyugalomvolgye@t-online.hu
Contact Person Name
Veronika Urbán
Contact Person Email
nyugalomvolgye@t-online.hu

Spain

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
510
Number Of Sites
13
Number Of Participants
65

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Respiratory
Principal Investigator Name
Ebymar Arismendi Nunez
Principal Investigator Email
earismen@clinic.cat
Contact Person Name
Ebymar Arismendi Nunez
Contact Person Email
earismen@clinic.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Respiratory
Principal Investigator Name
Astrid Crespo Lessmann
Principal Investigator Email
acrespo@santpau.cat
Contact Person Name
Astrid Crespo Lessmann
Contact Person Email
acrespo@santpau.cat
Site Name
Hospital Universitario De La Princesa
Department Name
Respiratory
Principal Investigator Name
Carolina Cisneros Serrano
Principal Investigator Email
carol9199@yahoo.es
Contact Person Name
Carolina Cisneros Serrano
Contact Person Email
carol9199@yahoo.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Respiratory
Principal Investigator Name
Jose Luis Velasco Garrido
Principal Investigator Email
jlvelascogarrido@hotmail.com
Contact Person Name
Jose Luis Velasco Garrido
Contact Person Email
jlvelascogarrido@hotmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Respiratory
Principal Investigator Name
Concepcion Morales Garcia
Contact Person Name
Concepcion Morales Garcia
Site Name
Hospital Universitario De Navarra
Department Name
Respiratory
Principal Investigator Name
Tamara Gutiérrez Urra
Principal Investigator Email
tamara.guitierrez.urra@navarra.es
Contact Person Name
Tamara Gutiérrez Urra
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Respiratory
Principal Investigator Name
Francisco Javier González Barcala
Contact Person Name
Francisco Javier González Barcala
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Respiratory
Principal Investigator Name
Luis Puente Maestu
Principal Investigator Email
luis.puente@salud.madrid.org
Contact Person Name
Luis Puente Maestu
Contact Person Email
luis.puente@salud.madrid.org
Site Name
Hospital Quironsalud Malaga
Department Name
Respiratory
Principal Investigator Name
Leticia Herrero Lifona
Principal Investigator Email
herrerolifona.leticia@gmail.com
Contact Person Name
Leticia Herrero Lifona
Site Name
Pectus Respiratory Health S.L.
Department Name
Research Facility
Principal Investigator Name
Juan Roldan Sanchez
Principal Investigator Email
juan.roldan@giromedinstitute.com
Contact Person Name
Juan Roldan Sanchez
Site Name
Accellacare Espana S.L.
Department Name
Respiratory
Principal Investigator Name
Jose Miguel Rodriguez Gonzalez-Moro
Principal Investigator Email
respirama@yahoo.es
Contact Person Name
Jose Miguel Rodriguez Gonzalez-Moro
Contact Person Email
respirama@yahoo.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Department of Pneumology
Principal Investigator Name
Carlos Martinez Rivera
Principal Investigator Email
carlosmartinezrivera.cmr@gmail.com
Contact Person Name
Carlos Martinez Rivera
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Respiratory
Principal Investigator Name
Jose Maria Echave Sustaeta
Principal Investigator Email
jose.echave@quironsalud.es
Contact Person Name
Jose Maria Echave Sustaeta
Contact Person Email
jose.echave@quironsalud.es

Sponsor

Primary sponsor

Full Name
Bellus Health Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Canada

Contract research organisations

Name
Syneos Health Clinique Inc.
Responsibilities
Pharmacokinetic analysis
Name
IQVIA Limited
Responsibilities
Cough diary; site network, eCOA, patient study costs management and concierge; equipment rental; other clinical operations tasks
Name
Sitero LLC
Responsibilities
IVRS30 – treatment randomisation; site support functions
Name
Cisys Inc.
Responsibilities
Eligibility criteria adjudication platform
Name
Q Squared Solutions Limited
Responsibilities
Clinical laboratory services (clinical chemistry, haematology, serology, pregnancy tests, SARS-CoV-2 tests, urine drug screen, urinalysis)
Name
Greenphire LLC
Responsibilities
Patient reimbursement management (ClinCard solutions)
Name
Vitalograph Limited
Responsibilities
Measurement of recorded cough frequency

Third parties

  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Pharmacokinetic analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursements","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple duties including cough diary; site network, eCOA, patient study costs management and concierge; equipment rental (other coded duties present)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Sitero LLC","duties_or_roles":"IVRS30 – treatment randomisation (and other coded duties)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Clinical chemistry, Clinical haematology, Serology/ endocrinology, serum pregnancy tests, SARS-CoV-2 tests, urine drug screen, urinalysis","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Glaxosmithkline Research & Development Limited","duties_or_roles":"SUSAR reporting","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Eligibility criteria adjudication platform","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vitalograph Limited","duties_or_roles":"Measurement of recorded cough frequency","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BLU-5937
Active Substance
CAMLIPIXANT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (prodAuthStatus=1)
Maximum Dose
1111 mg

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